Synopsis
Synopsis
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JDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONSUS Medicaid
NA
Annual Reports
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Regulatory FDF Prices
NA
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FDF
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Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
1. Cellcept
2. Mofetil Hydrochloride, Mycophenolate
3. Mofetil, Mycophenolate
4. Mycophenolate Mofetil
5. Mycophenolate Mofetil Hydrochloride
6. Mycophenolate, Sodium
7. Mycophenolic Acid
8. Mycophenolic Acid Morpholinoethyl Ester
9. Myfortic
10. Rs 61443
11. Rs-61443
12. Rs61443
13. Sodium Mycophenolate
1. 37415-62-6
2. Sodium Mycophenolate
3. Mycophenolic Acid Sodium Salt
4. Mycophenolic Acid Monosodium Salt
5. Erl 080
6. Mycophenolate Sodium [usan]
7. Sodium Mycophenalate
8. Erl-080
9. Mycophenolic Acid, Sodium Salt
10. Wx877sqi1g
11. Chebi:67155
12. Sodium;(e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-2-benzofuran-5-yl)-4-methylhex-4-enoate
13. Nsc-116072
14. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, Sodium Salt(1:1) , (4e)-
15. Mycophenolic Acid (sodium)
16. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, Monosodium Salt, (4e)-
17. Sodium 4(e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate
18. Sodium (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate
19. Unii-wx877sqi1g
20. Nsc 116072
21. Femulan
22. Erl 080a
23. Mycophenolic Sod
24. Myfortic (tn)
25. Ec-mps
26. Starbld0043375
27. Mycophenolatesodium
28. Mycophenolate Sodium (usp)
29. 4-hexenoic Acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, Monosodium Salt, (e)-
30. Erl-080a
31. Schembl1649229
32. Chembl2106643
33. Hy-b0421a
34. Mycophenolate Sodium [vandf]
35. Mycophenolate Sodium [mart.]
36. Mycophenolate Sodium [usp-rs]
37. Mycophenolate Sodium [who-dd]
38. Akos015969286
39. 4-hexenoic Acid, 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-, Sodium Salt
40. As-17786
41. Mycophenolate Sodium [ep Monograph]
42. Mycophenolic Acid Sodium Salt [mi]
43. Mycophenolate Sodium [usp Monograph]
44. Cs-0103129
45. D05095
46. D93087
47. Q27135653
48. Sodium (4e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoate
49. Sodium;(e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1h-2-benzofuran-5-yl)-4-methylhex-4-enoic Acid
| Molecular Weight | 342.3 g/mol |
|---|---|
| Molecular Formula | C17H19NaO6 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 6 |
| Exact Mass | 342.10793260 g/mol |
| Monoisotopic Mass | 342.10793260 g/mol |
| Topological Polar Surface Area | 95.9 Ų |
| Heavy Atom Count | 24 |
| Formal Charge | 0 |
| Complexity | 492 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Antibiotics, Antineoplastic
Chemical substances, produced by microorganisms, inhibiting or preventing the proliferation of neoplasms. (See all compounds classified as Antibiotics, Antineoplastic.)
Antibiotics, Antitubercular
Substances obtained from various species of microorganisms that are, alone or in combination with other agents, of use in treating various forms of tuberculosis; most of these agents are merely bacteriostatic, induce resistance in the organisms, and may be toxic. (See all compounds classified as Antibiotics, Antitubercular.)
Enzyme Inhibitors
Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)
API SUPPLIERS
Jai Radhe Sales is your partner for all your sourcing needs.
Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35848
Submission : 2021-06-24
Status : Active
Type : II
Certificate Number : CEP 2022-444 - Rev 00
Issue Date : 2024-09-20
Type : Chemical
Substance Number : 2813
Status : Valid
NDC Package Code : 52076-6236
Start Marketing Date : 2020-03-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24129
Submission : 2010-09-02
Status : Active
Type : II
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35722
Submission : 2021-03-31
Status : Active
Type : II
Certificate Number : R0-CEP 2021-335 - Rev 00
Issue Date : 2022-10-19
Type : Chemical
Substance Number : 2813
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-15
Pay. Date : 2020-09-29
DMF Number : 24397
Submission : 2010-11-19
Status : Active
Type : II
NDC Package Code : 66499-0039
Start Marketing Date : 2021-01-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33676
Submission : 2019-03-25
Status : Active
Type : II
NDC Package Code : 14593-928
Start Marketing Date : 2023-09-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (6kg/6kg)
Marketing Category : BULK INGREDIENT
Registrant Name : 엠피크코리아(주)
Registration Date : 2023-04-14
Registration Number : 20230414-209-J-1476
Manufacturer Name : Emcure Pharmaceuticals Limited
Manufacturer Address : Plot No. D-24 & D-24/1, Kurkumbh MIDC, Tal. Daund, Pune-413802, Maharashtra State India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40828
Submission : 2024-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39963
Submission : 2024-06-25
Status : Active
Type : II
Certificate Number : CEP 2022-433 - Rev 00
Issue Date : 2024-07-16
Type : Chemical
Substance Number : 2813
Status : Valid
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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FDF Dossiers
Regulatory Info : RX
Registration Country : USA
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 180MG BASE
Packaging :
Approval Date : 2021-02-10
Application Number : 214376
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 180MG BASE
Packaging :
Approval Date : 2021-11-29
Application Number : 214630
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 360MG BASE
Packaging :
Approval Date : 2023-11-29
Application Number : 217031
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 360MG BASE
Packaging :
Approval Date : 2019-12-13
Application Number : 211173
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 360MG BASE
Packaging :
Approval Date : 2024-05-29
Application Number : 216637
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)
Brand Name : JAMP MYCOPHENOLIC ACID
Dosage Form : TABLET (ENTERIC-COATED)
Dosage Strength : 360MG
Packaging :
Approval Date :
Application Number : 2518511
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 180MG BASE
Packaging :
Approval Date : 2014-01-08
Application Number : 91248
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 180MG BASE
Packaging :
Approval Date : 2014-10-30
Application Number : 202720
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Axympa
Dosage Form : GASTRO
Dosage Strength : 180 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info : RX
Registration Country : USA
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 360MG BASE
Packaging :
Approval Date : 2021-11-03
Application Number : 214289
Regulatory Info : RX
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : No
TE Code : AB
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 180MG BASE
Approval Date : 2017-08-23
Application Number : 202555
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 360MG BASE
Approval Date : 2021-09-23
Application Number : 208315
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 180MG BASE
Approval Date : 2012-08-21
Application Number : 91558
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 360MG BASE
Approval Date : 2014-08-19
Application Number : 91558
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 360MG BASE
Approval Date : 2021-11-29
Application Number : 214630
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 180MG BASE
Approval Date : 2023-11-29
Application Number : 217031
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 180MG BASE
Approval Date : 2019-12-13
Application Number : 211173
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 360MG BASE
Approval Date : 2019-12-13
Application Number : 211173
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 180MG BASE
Approval Date : 2024-05-29
Application Number : 216637
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : MYCOPHENOLIC SODIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : EQ 360MG BASE
Approval Date : 2024-05-29
Application Number : 216637
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Regulatory Info :
Registration Country : Sweden
Brand Name : Axympa
Dosage Form : GASTRO
Dosage Strength : 180 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Axympa
Dosage Form : GASTRO
Dosage Strength : 360 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info : Prescription
Registration Country : Canada
MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)
Brand Name : APO-MYCOPHENOLIC ACID
Dosage Form : TABLET (ENTERIC-COATED)
Dosage Strength : 180MG
Packaging : 120
Approval Date :
Application Number : 2372738
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)
Brand Name : APO-MYCOPHENOLIC ACID
Dosage Form : TABLET (ENTERIC-COATED)
Dosage Strength : 360MG
Packaging : 120
Approval Date :
Application Number : 2372746
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)
Brand Name : JAMP MYCOPHENOLIC ACID
Dosage Form : TABLET (ENTERIC-COATED)
Dosage Strength : 360MG
Packaging :
Approval Date :
Application Number : 2518511
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)
Brand Name : JAMP MYCOPHENOLIC ACID
Dosage Form : TABLET (ENTERIC-COATED)
Dosage Strength : 180MG
Packaging :
Approval Date :
Application Number : 2518538
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)
Brand Name : MAR-MYCOPHENOLIC ACID
Dosage Form : TABLET (ENTERIC-COATED)
Dosage Strength : 180MG
Packaging :
Approval Date :
Application Number : 2511673
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)
Brand Name : MAR-MYCOPHENOLIC ACID
Dosage Form : TABLET (ENTERIC-COATED)
Dosage Strength : 360MG
Packaging :
Approval Date :
Application Number : 2511681
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)
Brand Name : MYFORTIC
Dosage Form : TABLET (ENTERIC-COATED)
Dosage Strength : 180MG
Packaging : 120
Approval Date :
Application Number : 2264560
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)
Brand Name : MYFORTIC
Dosage Form : TABLET (ENTERIC-COATED)
Dosage Strength : 360MG
Packaging : 120
Approval Date :
Application Number : 2264579
Regulatory Info : Prescription
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Transwel 180
Dosage Form : TAB
Dosage Strength : 180mg
Packaging : 120X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Transwel 360
Dosage Form : TAB
Dosage Strength : 360mg
Packaging : 120X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Regulatory Info :
Registration Country : Turkey
Brand Name : MIKA
Dosage Form : TABLET
Dosage Strength : 180MG
Packaging : 120 TABLETS
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging : 120 TABLETS
Regulatory Info :
Dosage : TABLET
Dosage Strength : 180MG
Brand Name : MIKA
Approval Date :
Application Number :
Registration Country : Turkey
Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form :
Dosage Strength : 360MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging :
Regulatory Info :
Dosage :
Dosage Strength : 360MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Turkey
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 18...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 180MG BASE
USFDA APPLICATION NUMBER - 50791
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 36...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 360MG BASE
USFDA APPLICATION NUMBER - 50791
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ABOUT THIS PAGE
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PharmaCompass offers a list of Mycophenolate Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mycophenolate Sodium manufacturer or Mycophenolate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mycophenolate Sodium manufacturer or Mycophenolate Sodium supplier.
PharmaCompass also assists you with knowing the Mycophenolate Sodium API Price utilized in the formulation of products. Mycophenolate Sodium API Price is not always fixed or binding as the Mycophenolate Sodium Price is obtained through a variety of data sources. The Mycophenolate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mycophenolate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mycophenolate Sodium, including repackagers and relabelers. The FDA regulates Mycophenolate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mycophenolate Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Mycophenolate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mycophenolate Sodium supplier is an individual or a company that provides Mycophenolate Sodium active pharmaceutical ingredient (API) or Mycophenolate Sodium finished formulations upon request. The Mycophenolate Sodium suppliers may include Mycophenolate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Mycophenolate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mycophenolate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Mycophenolate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Mycophenolate Sodium DMFs exist exist since differing nations have different regulations, such as Mycophenolate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mycophenolate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Mycophenolate Sodium USDMF includes data on Mycophenolate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mycophenolate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Mycophenolate Sodium Drug Master File in Korea (Mycophenolate Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mycophenolate Sodium. The MFDS reviews the Mycophenolate Sodium KDMF as part of the drug registration process and uses the information provided in the Mycophenolate Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mycophenolate Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Mycophenolate Sodium API can apply through the Korea Drug Master File (KDMF).
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A Mycophenolate Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Mycophenolate Sodium Certificate of Suitability (COS). The purpose of a Mycophenolate Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mycophenolate Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mycophenolate Sodium to their clients by showing that a Mycophenolate Sodium CEP has been issued for it. The manufacturer submits a Mycophenolate Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mycophenolate Sodium CEP holder for the record. Additionally, the data presented in the Mycophenolate Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mycophenolate Sodium DMF.
A Mycophenolate Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mycophenolate Sodium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Mycophenolate Sodium written confirmation (Mycophenolate Sodium WC) is an official document issued by a regulatory agency to a Mycophenolate Sodium manufacturer, verifying that the manufacturing facility of a Mycophenolate Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mycophenolate Sodium APIs or Mycophenolate Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Mycophenolate Sodium WC (written confirmation) as part of the regulatory process.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Mycophenolate Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mycophenolate Sodium API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Mycophenolate Sodium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Mycophenolate Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mycophenolate Sodium NDC to their finished compounded human drug products, they may choose to do so.
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Mycophenolate Sodium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Mycophenolate Sodium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Mycophenolate Sodium GMP manufacturer or Mycophenolate Sodium GMP API supplier for your needs.
A Mycophenolate Sodium CoA (Certificate of Analysis) is a formal document that attests to Mycophenolate Sodium's compliance with Mycophenolate Sodium specifications and serves as a tool for batch-level quality control.
Mycophenolate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Mycophenolate Sodium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Mycophenolate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Mycophenolate Sodium EP), Mycophenolate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mycophenolate Sodium USP).
